FDA Approves Concussion Test, EyeBOX

The US Food and Drug Administration (FDA) has approved Oculogica’s EyeBOX, the first non-invasive, baseline-free tool directed at diagnosing concussions. It is intended for use in pediatric patients aged 5 years and in older adults aged up to 67 years.

By using eye-tracking that provides objective information, the device aids in assessing patients with suspected concussion through an easy to take, 4-minute test. With over 2.5 million emergency room visits in the United States as a result of head injuries, the device has potential to serve a large population.

“Before now, concussion assessments have relied on subjective measures or baseline testing,” Rosina Samadani, PhD, CEO of Oculogica, said in a recent statement. “This authorization by the FDA is a significant milestone for … a new era for concussion diagnosis and management for patients and healthcare practitioners.”

Other diagnostics can require a baseline test, which is often generated at the beginning of a sport season, pre-injury, and is compared to subsequent test results at the time of a suspected concussion. However, when evaluating trauma patients in the emergency room, a baseline concussion assessment is not feasible in many situations. Additionally, athletes and military personnel can sometimes “game” or memorize baseline tests so that they pass a subsequent test.

As a result, the baseline-free EyeBOX stands as a major advancement in the field with its unique eye-tracking algorithm.

“Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients,” Robert Spinner, MD, chair of the Department of Neurological surgery at Mayo Clinic, said. “The result will be more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the field.”

Christina Master, MD, attending physician at the Children’s Hospital of Philadelphia, added that the previously existing lack of objective measures in her field make EyeBOX all the more monumental. As part of an objective, multimodal assessment, the device will stand as an important advance for patients.

The pivotal DETECT trial, which included 282 patients at six independent clinical sites in the United States, served as the basis for the approval. Enrolled patients were suspected of having traumatic brain injury (TBI) who presented in the emergency room and concussion clinic composed the foundation of the Oculogica De Novo application.

Among the results, EyeBOX demonstrated high sensitivity to the presence of concussion. Negative EyeBOX results were consistent with a lack of concussion, which supplied objective data in the evaluation of patients with suspected TBI.

“Looking beyond this milestone, EyeBOX has the potential to aid in the diagnosis of other neurological conditions and may benefit researchers developing therapies for TBI and concussion,” John Leddy, MD, medical director of the University at Buffalo Concussion Management Clinic, said in a statement. “Development of treatments for concussion is challenging because there are few reliable outcome measures. EyeBOX may offer one solution to this challenge, providing researchers with an objective oculomotor assessment tool.”